About Us

Organization structure

Organization structure

 

  

Responsibilities of sections

1. Chemical and Physical Testing Section

Chemical and Physical Testing Section is divided into four laboratories: Chemical and Physical Testing Laboratory 1, 2, 3 and 4. Their responsibilities are as follows:

  • perform both physical and chemical analysis of pharmaceutical products
  • testing of imported active pharmaceutical ingredients (API) to ensure their compliance with established specification
  • conduct research programme to develop new testing methods
  • develop and transfer analytical technology to government and private laboratories
  • develop test kit for screening test of drug substances and adulterations
  • qualitative analysis of seized materials

2. Narcotic Section

Narcotic Section consists of three laboratories: Narcotic Laboratory 1, 2 and 3. Their responsibilities are as follows:

2.1 Narcotic Laboratory 1

  • confirmatory test of narcotics in urine specimens
  • develop standard test methods
  • develop test kit for screening test of psychotropic and narcotic substances
  • conduct survey for drug abuse

2.2 Narcotic Laboratory 2

  • qualitative and quantitative analysis of illicit drugs
  • develop standard test methods
  • develop test kit for screening test of psychotropic and narcotic substances
  • conduct survey for drug abuse.

2.3 Narcotic Laboratory 3

  • chemical analysis for psychotropic and narcotic substances used as medicines
  • qualitative and quantitative analysis of illicit drugs
  • develop standard test methods
  • develop test kit for screening test of psychotropic and narcotic substances
  • conduct survey for drug abuse.

3. Biological Testing Section 

Biological Testing Section consists of three laboratories: Biological Testing Laboratory 1, 2 and 3. Their responsibilities are as follows:

3.1 Biological Testing Laboratory 1

  • analysis of antibiotics using microbiological methods
  • contamination testing of analysis of non-sterile pharmaceutical products
  • sterility testing of parenteral products
  • conduct research programme to develop new testing methods
  • develop and transfer analytical technology to government and private laboratories

3.2 Biological Testing Laboratory 2

  • research and development on biopharmaceutical products
  • development of standard method for quality control of biopharmaceutical products including biosimilars
  • post-marketing surveillance of biopharmaceutical products including biosimilars
  • provide technical support and training to government and private sectors

3.3  Biological Testing Laboratory 3

  • pyrogen / bacterial endotoxin testing of parenteral products
  • biocompatibility testing of plastics and polymers
  • conduct research programme to develop new testing methods
  • develop and transfer analytical technology to government and private laboratories

4.  Quality and Technical Development Section

  • prepare strategic plan, action plan, budget, personnel development, coordinate and organizes local as well as international training programmes
  • coordinate quality assurance activities to ensure that all laboratory activities are performed according to laboratory quality system
  • planning for instrument calibration according to quality system
  • IT programme developing for the Bureau
  • coordinate the proficiency testing programme to assess laboratory performance

5. Thai Pharmacopoeia Section

  • study on various aspects of drugs and preparations e.g. their pharmacology, chemistry, including testing the methods for identification and assays in order to establish their specifications in the Thai Pharmacopoeia
  • publish the successive volume of Thai Herbal Pharmacopoeia
  • issue the Pharmacopoeial Newsletter

6. Reference Standard Center

  • establish drug and narcotic reference substances for locally use and within ASEAN member countries
  • training center for the production of ASEAN reference substances for member countries

7. Administrative Office

  • receive and dispatch official papers
  • type analytical reports and official correspondence
  • filing and archiving documents
  • procurement of laboratory, scientific as well as office supplies
  • maintain accounting, administrative budget management and personnel services
  • serve as central registry for incoming sample